OCS Liver DCD Trial

N/ATerminatedNCT04194437

TransMedics9 enrolled

Overview

Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Transplant

Interventions

OCS Liver SystemDEVICE

The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Registered primary liver transplant candidate * Age ≥ 18 years * Obtained informed consent Exclusion Criteria: * Acute, fulminant liver failure * Prior solid organ or bone marrow transplant * Ventilator dependent on day of transplant/donor organ offer

Locations (4)

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mount Sinai Hospital

New York, New York, United States

University of Texas San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Liver Graft Survival Through 6 Months Post-transplant

Evaluation of graft survival as defined per UNOS data collection criteria for graft status after liver transplantation

Time frame: 6 months

Data from ClinicalTrials.gov

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